Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00111163
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2005-05-17
Brief Title:
Intermittent Preventive Treatment With Antimalarials in Kenyan Infants
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
Efficacy and Safety of Pediatric Immunization-linked Preventive Intermittent Treatment With Antimalarials in Decreasing Anemia and Malaria Morbidity in Rural Western Kenya
Status:
COMPLETED
Status Verified Date:
2012-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to see whether antimalarial drugs administered at the time of routine infant vaccinations prevents malaria and anemia in the first year of life
Detailed Description:
Approximately three quarters of preschool children in eastern Africa suffer from anemia defined as a hemoglobin Hb concentration below 11 gdL For children 5 years of age the overall incidence of severe malarial anemia Hb 5 gdl is estimated at 15-60 cases per 1000 children per year Other studies have confirmed that the burden of malaria-related anemia falls primarily on infants and young children In 2000 Schellenberg and colleagues working in an area of Tanzania with a low to moderate level of Plasmodium falciparum transmission and a low level of sulfadoxine-pyrimethamine SP resistance demonstrated that by linking intermittent prophylaxis to routine immunization visits through the national Expanded Program on Immunization EPI SP could be administered to children at 23 and 9 months of age resulting in a 59 reduction in rates of clinical malaria and a 50 reduction in the rate of severe anemia Hb8 gdl compared to those receiving placebo This randomized double blind placebo-controlled trial is being conducted to estimate the efficacy of Intermittent Preventive Treatment for Infants IPTi with SP three doses of artesunate AS SPAS3 given in combination with iron supplementation from 2-6 months of age at routine EPI visits on the prevention of clinical malaria moderate anemia and severe anemia in the first 18 months of life in an area with intense malaria transmission and near universal ownership of insecticide treated nets ITNs The primary objective is to compare the efficacy of iron supplementation and IPTi with one of 3 antimalarial regimens SPAS3 chlorproguanil-dapsone Lapdap or AQAS3 given at routine EPI visits with iron supplementation alone placebo on the prevention of clinical malaria in the first year of life Specific secondary objectives are 1 Compare the efficacy of iron supplementation plus IPTi with one of 3 antimalarial regimens SPAS3 Lapdap chlorproguanil-dapsone or AQAS3 given at routine EPI visits with iron supplementation alone placebo on the prevention of moderate and severe anemia in the first year of life 2 Assess the impact of IPTi with the aforementioned regimens on serologic responses to EPI vaccines Polio Diphtheria Tetanus Pertussis Hepatitis B Hemophilus Influenzae type B and Measles 3 Assess the impact of IPTi with the aforementioned regimens particularly SPAS3 on the nasal carriage rates of Haemophilus influenza type b and 4 Compare the efficacy of iron supplementation and IPTi with one of 3 antimalarial regimens SPAS3 Lapdap chlorproguanil-dapsone or AQAS3 given at routine EPI visits with iron supplementation alone placebo on the prevention of all-cause hospitalization in the first year of life This trial will generate important public health information on the efficacy of IPTi in preventing anemia and clinical malaria among infants in an area with intense malaria transmission and ongoing prevention efforts through the use of insecticide treated nets This trial will contribute towards understanding IPTis mechanism of action ie through intermittent clearance of parasites vs a chemoprophylactic effect afforded through the use of an antimalarial with a long half-life The information gained will be useful to determine the safety of IPTi and to decide what sort of antimalarials are appropriate for IPTi and ultimately will help to direct child survival and malaria control policy in African countries If alternative drug regimes to SP prove effective that information will be valuable to policymakers as levels of P falciparum resistance to SP rise with increased usage in east Africa
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SSC 701 | None | None | None |